FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
130081–130104 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 23, 1989
LATEX EXAMINATION GLOVES (WINTEX)
K892174 · LYY
Windwell Agencies Sdn. Bhd.
General Hospital · 140d
Cleared Aug 23, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892177 · LYY
Chem-Specialties Sdn Bhd
General Hospital · 140d
Cleared Aug 23, 1989
PEGASYS NUCLEAR MEDICINE IMAGING COMPUTER
K892358 · KPS
Adac Laboratories
Radiology · 139d
Cleared Aug 23, 1989
KOBAYASHI HOOK AND TWIST KOBAYASHI HOOK
K893655 · EJF
American Orthodontics
Dental · 100d
Cleared Aug 23, 1989
HIGH NOBLE, TYPE III DENTAL CASTING ALLOY
K893688 · EJT
Jelenko Co.
Dental · 99d
Cleared Aug 23, 1989
KALTOCARB WOUND DRESSING
K894347 · FRO
Calgon Vestal Div.
General & Plastic Surgery · 40d
Cleared Aug 23, 1989
SAFESKIN POWDRED HYPOALLERGENIC STERIL SURG GLOVES
K894354 · KGO
Safeskin Corp.
General Hospital · 40d
Cleared Aug 23, 1989
DIRECTABLE COAXIAL CATHETER SET
K894716 · GCJ
Cook Ob/Gyn
General & Plastic Surgery · 29d
Cleared Aug 23, 1989
IRRIGATOR STAND
K894891 · HDC
Commercial Products & Engineering Co.
Obstetrics & Gynecology · 22d
Cleared Aug 23, 1989
2ND SKIN NON-STICK MOIST BURN PADS
K894898 · FRO
Spenco Medical Corp.
General & Plastic Surgery · 22d
Cleared Aug 22, 1989
ABSORBABLE SURGICAL GUT SUTURE*
K885018 · GAL
United States Surgical, A Division of...
General & Plastic Surgery · 260d
Cleared Aug 22, 1989
INFRARED HEX
K890585 · ILY
Healthteam
Physical Medicine · 197d
Cleared Aug 22, 1989
INFRARED DELUXE
K890586 · ILY
Healthteam
Physical Medicine · 197d
Cleared Aug 22, 1989
PATIENT EXAMINATION GLOVE (LATEX)
K891136 · LYY
Advance Rubber, Inc.
General Hospital · 172d
Cleared Aug 22, 1989
BIOSHIELD AND UNIVERSAL LATEX EXAM GLOVES
K891268 · LYY
Dah Lee Rubber Industries (Thai) , Ltd.
General Hospital · 166d
Cleared Aug 22, 1989
GLOUCH(TM) PATIENT EXAMINATION GLOVES
K891833 · LZA
Vadax, Inc.
General Hospital · 148d
Cleared Aug 22, 1989
VINYL EXAM GLOVES (MFG. TSE FONG)
K892317 · LYZ
Svenska Medita Ac.
General Hospital · 138d
Cleared Aug 22, 1989
VINYL EXAM GLOVES (MFG. UNIVERSAL GLOVE CORP.)
K892318 · LYZ
Svenska Medita Ac.
General Hospital · 138d
Cleared Aug 22, 1989
LATEX EXAM GLOVES (MFG. KOSSAN LATEX INDUSTRIES)
K892319 · LYY
Svenska Medita Ac.
General Hospital · 138d
Cleared Aug 22, 1989
HONYEE VINYL EXAMINATION GLOVES
K893822 · LYZ
Honyee Enterprise Co.
General Hospital · 91d
Cleared Aug 22, 1989
CVIS ULTRA-SCAN ONE IMAGING CATHETER
K893837 · IYO
Cardiovascular Imaging Systems, Inc.
Radiology · 90d
Cleared Aug 22, 1989
DAVIS+GECK VISADUCT KIT
K894685 · LRO
Davis & Geck, Inc.
General & Plastic Surgery · 28d
Cleared Aug 21, 1989
BIOMETER AUDIOMETER
K883505 · EWO
Micro Audiometrics Corp.
Ear, Nose, Throat · 369d
Cleared Aug 21, 1989
MODIFIED TOUCH-ME-NOT MASK
K884157 · BSJ
Walt'S Products
Anesthesiology · 321d